US20240207509A1 - System and method for detecting fluid type in tubing for fluid injector apparatus - Google Patents

System and method for detecting fluid type in tubing for fluid injector apparatus Download PDF

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Publication number
US20240207509A1
US20240207509A1 US18/560,984 US202218560984A US2024207509A1 US 20240207509 A1 US20240207509 A1 US 20240207509A1 US 202218560984 A US202218560984 A US 202218560984A US 2024207509 A1 US2024207509 A1 US 2024207509A1
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Prior art keywords
fluid
path section
fluid path
detector
reservoir
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US18/560,984
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English (en)
Inventor
Richard Morton
Christopher Scutt
Michael Spohn
Randy Lee
Mikayla FERCHAW
Kevin Cowan
Patrick Campbell
Andrew Naples
William Barone
Christopher Capone
Curtis Pastor
Charles Lang
Michael Swantner
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Bayer Healthcare LLC
Bayer Healthcare LLC
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Bayer Healthcare LLC
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Priority to US18/560,984 priority Critical patent/US20240207509A1/en
Assigned to BAYER HEALTHCARE LLC reassignment BAYER HEALTHCARE LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: LANG, CHARLES, SWANTNER, MICHAEL
Assigned to LLC, BAYER HEALTHCARE, BAYER HEALTHCARE LLC reassignment LLC, BAYER HEALTHCARE ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PASTOR, Curtis, LEE, RANDY, BARONE, William, CAPONE, CHRISTOPHER, FERCHAW, Mikayla, HAURY, JOHN, MORTON, RICHARD, NAPLES, Andrew, SCUTT, CHRISTOPHER, SPOHN, MICHAEL, COWAN, KEVIN
Publication of US20240207509A1 publication Critical patent/US20240207509A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1407—Infusion of two or more substances
    • A61M5/1408—Infusion of two or more substances in parallel, e.g. manifolds, sequencing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14546—Front-loading type injectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804—Flow controllers
    • A61M5/16827—Flow controllers controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/36—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests with means for eliminating or preventing injection or infusion of air into body
    • A61M5/365—Air detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/48—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for varying, regulating, indicating or limiting injection pressure
    • A61M5/482—Varying injection pressure, e.g. by varying speed of injection
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    • A61M2005/1401—Functional features
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    • A61M2005/1401—Functional features
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/584—Means for facilitating use, e.g. by people with impaired vision by visual feedback having a color code
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements

Definitions

  • the present disclosure is related to the field of fluid injector and apparatus for injecting contrast media for contrast enhanced medical imaging procedures.
  • embodiments of a system and method for detecting air and fluid type (contrast and saline) and fluid concentration in a fluid tubing set of the fluid injector apparatus are described.
  • a medical practitioner injects a patient with one or more medical fluids.
  • medical fluids such as an imaging contrast media solution (often referred to simply as “contrast”), a flushing agent, such as saline or Ringer's lactate, and other medical fluids
  • CV cardiovascular angiography
  • CT computed tomography
  • MRI magnetic resonance imaging
  • PET positron emission tomography
  • these fluid injectors are designed to deliver a preset amount of fluid at a preset pressure, duration, and/or flow rate.
  • fluid injectors have at least one drive member, such as a piston, that connects to the syringe, for example via connection with a plunger or an engagement feature on a proximal end wall of the syringe.
  • the fluid injector may include one or more peristaltic pumps for injecting the medical fluid from a fluid reservoir.
  • the syringe may include a rigid barrel with a syringe plunger slidably disposed within the barrel.
  • the drive members drive the plungers in a proximal and/or distal direction relative to a longitudinal axis of the barrel to draw fluid into or deliver the fluid from the syringe barrel, respectively.
  • the medical fluids are injected into the vascular system at fluid pressures up to 300 psi for CT imaging procedures or up to 1200 psi, for example for CV imaging procedures.
  • the present disclosure provides systems, devices, and methods for detecting the contents in a fluid line during a medical fluid injection procedure.
  • Certain embodiments of the present disclosure are directed to a fluid injector system.
  • the system includes at least one injector for pressurizing and delivering at least one fluid from at least one fluid reservoir, at least one fluid path section providing fluid communication between a bulk fluid reservoir and a syringe connected to the at least one injector, and at least one sensor arranged along the at least one fluid path section.
  • the at least one sensor includes an emitter configured to emit light through the at least one fluid path section, and a detector configured to receive the light emitted through the at least one fluid path section and generate an electrical signal based on at least one property of the received light.
  • the system further includes at least one processor programmed or configured to determine, based on the electrical signal generated by the detector, at least one of an identity of the at least one fluid present in the fluid path section, a concentration of the at least one fluid in the fluid path section, and at least one property of the fluid path section.
  • the emitter is arranged on a first side of the fluid path section
  • the detector is arranged on a second side of the fluid path section
  • the second side of the fluid path section is approximately 180° opposite the first side of the fluid path section.
  • the fluid injector system further includes a first fluid reservoir and a second fluid reservoir for delivering a first fluid and a second fluid, respectively.
  • the system further includes a first fluid path section in fluid communication with the first fluid reservoir, a second fluid path section in fluid communication with the second fluid reservoir, and a first sensor and a second sensor.
  • the first fluid path section is associated with the first sensor and the second fluid path section is associated with the second sensor.
  • the fluid injector system further includes a first bulk fluid container in fluid communication with the first fluid reservoir and a second bulk fluid container in fluid communication with the second fluid reservoir.
  • the first sensor is arranged to detect fluid entering the first fluid reservoir from the first bulk fluid container during a filling operation of the first fluid reservoir
  • the second sensor is arranged to detect fluid entering the second fluid reservoir from the second bulk fluid container during a filling operation of the second fluid reservoir.
  • the at least one processor is programmed or configured to determine, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir.
  • the at least one processor is programmed or configured to perform an operation selected from: halting the filling operation in response to determining that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and adjusting an injection protocol to ensure that injection parameters are updated to switch the identity of the first fluid reservoir and the second fluid reservoir so that first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir.
  • the at least one processor is programmed or configured to alter the injection protocol by configuring the first fluid reservoir to inject the fluid originally intended to be injected by the second fluid reservoir; and configuring the second fluid reservoir to inject the fluid originally intended to be injected by the first fluid reservoir.
  • the at least one processor is programmed or configured to adjust a display of a graphical user interface or to illuminate a light source associated with the fluid reservoirs to indicate that the first fluid reservoir contains the fluid originally intended to be injected by the second fluid reservoir, and that the second fluid reservoir contains the fluid originally intended to be injected by the first fluid reservoir.
  • the fluid injector system further includes a manifold.
  • the manifold includes the at least one fluid path section, an inlet port connected to a syringe tip of the at least one fluid reservoir, an outlet port connected to a patient line, and a fill port connected to a bulk fluid container.
  • the least one processor is programmed or configured to determine, based on at least one of identity of the fluid and concentration of the fluid in the at least one fluid path section, an optimal fill rate of the at least one fluid reservoir.
  • the optimal fill rate includes a fastest speed of filling the at least one fluid reservoir that minimizes introduction of bubbles into the fluid as it enters the at least one fluid reservoir.
  • the detector is configured to output a first voltage signal when the at least one fluid path section contains contrast media.
  • the detector is configured to output a second voltage signal when the fluid path section contains saline.
  • the at least one processor is programmed or configured to determine the identity of the injection fluid in the at least one fluid path section based on a difference between the first voltage signal and the second voltage signal.
  • the detector is configured to output a third voltage signal when the at least one fluid path section contains air.
  • the at least one processor is programmed or configured to determine that air is in the at least one fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.
  • the detector when the detector determines that the fluid path section contains air, the detector is configured to provide an alert to a user that the bulk fluid reservoir is empty.
  • the at least one processor is programmed or configured to determine a concentration of a contrast media in the at least one fluid path section based on the electrical signal generated by the at least one sensor and increase a ratio of saline injected during an injection procedure to dilute the concentration of the contrast media delivered to the patient.
  • the at least one processor is programmed or configured to determine a concentration of a contrast media in the fluid path section based on the electrical signal generated by the at least one sensor and reduce an injection rate of saline during an injection procedure to increase the concentration of the contrast media delivered to the patient.
  • the emitter is arranged to emit light perpendicular to a fluid flow direction through the at least one fluid path section.
  • the at least one processor is programmed or configured to determine, based on the electrical signal, that the at least one fluid path section is present between the emitter and the detector.
  • the emitter is configured to emit light on the ultraviolet spectrum.
  • the emitted light may have a wavelength from about 300 nm to about 400 nm.
  • the emitter is configured to emit light on the infrared spectrum.
  • the emitted light may have a wavelength from about 700 nm to about 2000 nm.
  • the emitter is configured to emit light on the visible spectrum.
  • the emitted light may have a wavelength from about 400 nm to about 700 nm.
  • the at least one processor is programmed or configured to drive the emitter at a first emitter current, the first emitter current is configured to saturate the detector if a first fluid is present in the fluid path section.
  • the at least one processor is programmed or configured to drive the emitter at a second emitter current greater than the first emitter current, the second emitter current is configured to saturate the detector if a second fluid is present in the fluid path section.
  • inventions of the present disclosure are direct to a method for determining one or more fluid properties of a fluid flowing in at least one fluid path section of a fluid injector system.
  • the method includes emitting light from an emitter of at least one sensor through the at least one fluid path section, detecting with a detector of the first proximal sensor the light that has passed through the at least one fluid path section, and determining, based on an electrical signal generated by the detector, at least one of an identity of an injection fluid present in the fluid path set, a concentration of the injection fluid in the fluid path set, and at least one property of the fluid path section.
  • the emitter is arranged on a first side of the fluid path section
  • the detector is arranged on a second side of the fluid path section
  • the second side of the fluid path section is approximately 180° opposite the first side of the fluid path section.
  • the fluid injector system includes a first fluid reservoir and a second fluid reservoir for delivering a first fluid and a second fluid, respectively, a first fluid path section in fluid communication with the first fluid reservoir, a second fluid path section in fluid communication with the second fluid reservoir, and a first sensor and a second sensor.
  • the first fluid path section is associated with the first sensor and the second fluid path section is associated with the second sensor.
  • the fluid injector system further includes a first bulk fluid container in fluid communication with the first fluid reservoir, and a second bulk fluid container in fluid communication with the second fluid reservoir.
  • the first sensor is arranged to detect fluid entering the first fluid reservoir during a filling operation of the first fluid reservoir
  • the second sensor is arranged to detect fluid entering the second fluid reservoir during a filling operation of the second fluid reservoir.
  • the method further includes determining, based on the electrical signals generated by the first and second sensors, that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir, and the fluid filling the second fluid reservoir was originally intended to fill the first fluid reservoir.
  • the method further includes halting the fill operation in response to determining that the fluid filling the first fluid reservoir was originally intended to fill the second fluid reservoir.
  • the method further includes adjusting an injection protocol to ensure that injection parameters are updated to switch the identity of the first fluid reservoir and the second fluid reservoir so that first fluid is associated with the first fluid reservoir and the second fluid is associated with the second fluid reservoir.
  • the method further includes altering an injection protocol by configuring the first fluid reservoir to inject the fluid originally intended to be injected by the second fluid reservoir and configuring the second fluid reservoir to inject the fluid originally intended to be injected by the first fluid reservoir.
  • the method further includes adjusting a display of a graphical user interface or illuminating a light source associated with the fluid reservoirs to indicate that the first fluid reservoir contains the fluid originally intended to be injected by the second fluid reservoir, and that the second fluid reservoir contains the fluid originally intended to be injected by the first fluid reservoir.
  • the fluid injector system further includes a manifold.
  • the manifold includes the at least one fluid path section, an inlet port connected to a syringe tip of the at least one fluid reservoir, an outlet port connected to a patient line, and a fill port connected to a bulk fluid container.
  • the method further includes determining, based on at least one of identity of the fluid and concentration of the fluid in the at least one fluid path section, an optimal fill rate of the at least one fluid reservoir.
  • the optimal fill rate includes a fastest speed of filling the at least one fluid reservoir that minimizes introduction of bubbles into the fluid as it enters the at least one fluid reservoir.
  • the detector is configured to output a first voltage signal when the at least one fluid path section contains contrast media.
  • the detector is configured to output a second voltage signal when the fluid path section contains saline.
  • the method further includes determining the identity of the injection fluid in the at least one fluid path section based on a difference between the first voltage signal and the second voltage signal.
  • the detector is configured to output a third voltage signal when the at least one fluid path section contains air.
  • the method further includes determining that air is in the fluid path section based on a difference between the third voltage signal, the first voltage signal, and the second voltage signal.
  • the method further includes providing an alert to a user that the bulk fluid reservoir is empty when the detector determines that the fluid path section contains air.
  • the method further includes determining a concentration of a contrast media in the at least one fluid path section based on the electrical signal generated by the at least one sensor; and increasing a ratio of saline injected during an injection procedure to dilute the concentration of the contrast media delivered to the patient.
  • the method further includes determining a concentration of a contrast media in the at least one fluid path section based on the electrical signal generated by the at least one sensor; and reducing an injection rate of saline during an injection procedure to increase the concentration of the contrast media delivered to the patient.
  • the emitter is arranged to emit light perpendicular to a fluid flow direction through the at least one fluid path section.
  • the method further includes determining, based on the electrical signal, that the at least one fluid path section is present between the emitter and the detector.
  • the emitter is configured to emit light on the ultraviolet spectrum.
  • the emitted light may have a wavelength from about 300 nm to about 400 nm.
  • the emitter is configured to emit light on the infrared spectrum.
  • the emitted light may have a wavelength from about 700 nm to about 2000 nm.
  • the emitter is configured to emit light on the visible spectrum.
  • the emitted light may have a wavelength from about 400 nm to about 700 nm.
  • the method further includes driving the emitter at a first emitter current, the first emitter current is configured to saturate the detector if a first fluid is present in the fluid path section.
  • the method further includes driving the emitter at a second emitter current greater than the first emitter current, the second emitter current is configured to saturate the detector if a second fluid is present in the fluid path section.
  • FIG. 1 is a perspective view of a fluid injector system according to an embodiment of the present disclosure
  • FIG. 2 is a schematic view of a fluid injector system according to an embodiment of the present disclosure
  • FIG. 3 is a front cross-sectional view of a sensor module according to an embodiment of the present disclosure
  • FIG. 4 is a front cross-sectional view of the sensor module of FIG. 3 associated with a liquid-filled fluid path section:
  • FIG. 5 is a front cross-sectional view of the sensor module of FIG. 3
  • FIG. 6 is a front view of a manifold and manifold housing module according to an embodiment of the present disclosure
  • FIG. 7 is a side cross-sectional view of a syringe tip, fluid path section, and a sensor module according to an embodiment of the present disclosure
  • FIG. 8 A is a histogram of sensor output voltage for various fluids in a fluid path section using infrared radiation, according to an embodiment of the present disclosure
  • FIG. 8 B is a plot of standard deviation of sensor output voltage from FIG. 8 A for various types of contrast media in a fluid path section using infrared radiation:
  • FIG. 9 is a graph of average sensor output voltage for various concentrations of contrast media in a fluid path section using infrared radiation, according to an embodiment of the present disclosure.
  • FIG. 10 is a graph of average sensor output voltage for various concentrations of contrast media in a fluid path section using ultraviolet radiation, according to an embodiment of the present disclosure
  • FIG. 11 is a graph of average sensor output voltage for various concentrations of contrast media in a fluid path section using ultraviolet radiation, according to an embodiment of the present disclosure
  • FIG. 12 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure
  • FIG. 13 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure
  • FIG. 14 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure.
  • FIG. 15 is a graph of relative electromagnetic transmission for various contrast media in a fluid path section, according to an embodiment of the present disclosure.
  • FIG. 16 is a front cross-sectional view of an eccentric fluid path section:
  • FIG. 17 is a side cross-sectional view of a fluid path section having a draft:
  • FIG. 18 is a side cross-sectional view of a fluid path section having a surface finish:
  • FIG. 19 is a front cross-sectional view of an out-of-round fluid path section:
  • FIG. 20 is a front cross-sectional view of a fluid path section having a wisp:
  • FIGS. 21 A- 21 H are graphs showing detector output voltage as a function of emitter current, according to embodiments of the present disclosure.
  • FIG. 22 is a graph of sensor output voltage over time for various conditions and configurations of a syringe cap:
  • FIG. 23 is a circuit schematic of a sensor according to an embodiment of the present disclosure.
  • FIG. 24 is a perspective view of a syringe tip, manifold, and sensor module according to an embodiment of the present disclosure.
  • a stated range or ratio of “1 to 10” should be considered to include any and all subranges or sub-ratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or sub-ratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less.
  • the ranges and/or ratios disclosed herein represent the average values over the specified range and/or ratio.
  • the terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.
  • the term “at least” is synonymous with “greater than or equal to”.
  • the term “not greater than” is synonymous with “less than or equal to”.
  • “at least one of” is synonymous with “one or more of”.
  • the phrase “at least one of A, B, and C” means any one of A. B, or C, or any combination of any two or more of A, B, or C.
  • “at least one of A, B, and C” includes A alone; or B alone; or C alone; or A and B; or A and C; or B and C; or all of A, B, and C.
  • the term “includes” is synonymous with “comprises”.
  • proximal refers to a portion of a syringe nearest a piston element for engaging with an end wall of the syringe and delivering fluid from a syringe.
  • proximal refers to a portion of the fluid path nearest to an injector system when the fluid path is connecting with the injector system.
  • distal refers to a portion of a syringe nearest to a delivery nozzle.
  • distal refers to a portion of the fluid path nearest to a patient when the fluid path is connected with an injector system.
  • radial refers to a direction in a cross-sectional plane normal to a longitudinal axis of a syringe extending between proximal and distal ends.
  • circumferential refers to a direction around an inner or outer surface of a sidewall of a syringe.
  • axial refers to a direction along a longitudinal axis of the syringe extending between the proximal and distal ends.
  • FIGS. 1 and 2 embodiments of a dual syringe fluid injector system 2000 are illustrated.
  • the fluid injector system 2000 is configured for injection of two medical fluids from respective fluid reservoirs 10 A, 10 B, which are illustrated as syringes in the accompanying drawings.
  • the first fluid reservoir 10 A contains an imaging contrast media for an angiography (CV), MRI, PET, or computed tomography (CT) injection procedure
  • the second fluid reservoir 10 B contains a flushing fluid, such as saline or Ringer's lactate.
  • contrast fluids are typically an aqueous solution of a contrast agent compound at a defined concentration.
  • Various contrast agent compounds at different concentrations are known in the art.
  • the fluids are injected from fluid reservoirs 10 A, 10 B through a series of fluid path elements connecting the fluid reservoirs 10 A, 10 B to a catheter 110 inserted into the vasculature system of a patient.
  • the fluid injector system 2000 may further include bulk fluid containers 19 A and 19 B for filling and refilling the respective syringes 10 A, 10 B with imaging contrast media and flushing fluid, respectively.
  • the system 2000 includes a fluid path set including a first syringe line 208 A in fluid communication with a tip or nozzle 16 A of the first syringe 10 A, a first fill line 216 A in fluid communication with the first bulk fluid container 19 A, and a first patient line 210 A in fluid communication with the catheter 110 .
  • the first syringe line 208 A, the first fill line 216 A, and/or the first patient line 210 A are fluidly connected at a manifold or T-connection (see, e.g. FIGS.
  • the fluid path set further includes a syringe line 208 B in fluid communication with a tip or nozzle 16 B of the second syringe 10 B, a fill line 216 B in fluid communication with the second bulk fluid container 19 B, and a patient line 210 B in fluid communication with the catheter 110 .
  • the syringe line 208 B, the fill line 216 B, and/or the patient line 210 B are fluidly connected at the manifold or T-connection (see, e.g. FIGS. 6 and 24 ).
  • the arrangement of the fluid path set allows fluid to be drawn from the first bulk fluid container 19 A into the first syringe 10 A via the first fill line 216 A and the first syringe line 208 A. Fluid can be injected from the first syringe 10 A to the patient via the first syringe line 208 A, the patient line 210 A, and the catheter 110 . Similarly, fluid may be drawn from the second bulk fluid container 19 B into the second syringe 10 B via the second fill line 216 B and the second syringe line 208 B. Fluid can be injected from the second syringe 10 B to the patient via the second syringe line 208 B, the second patient line 210 B, and the catheter 110 .
  • the syringe lines 208 A, 208 B, the fill lines 216 A, 216 B, and the outlet lines 210 A, 210 B may be made of flexible tubing, although various portions thereof, for example luer connectors, sensor regions and mixing chambers may be rigid. While the fluid injector 12 illustrated in FIGS. 1 and 2 is shown with a first contrast syringe and a second flushing fluid syringe, in certain injection procedures, only contrast may be used, with no associated flushing fluid. According to these embodiments, the fluid injector 12 may be engaged with only a first syringe 10 A and associated first bulk reservoir 19 A and fluid path components for injecting the contrast into a patient. The flush side of the fluid injector 12 may be left empty during such a single fluid injection procedure. Alternatively, a fluid injector (not shown) configured for engagement with only a single syringe may utilize the various embodiments of sensor modules and methods described herein.
  • PCT/US2013/061275 PCT/US2018/034613; PCT/US2020/049885; PCT/US2021/035273; PCT/US2021/029963; PCT/US2021/018523; PCT/US2021/037623; PCT/US2021/037574; and PCT/US2021/045298, the disclosures of which are hereby incorporated by reference in their entireties.
  • the injector system 2000 includes a first piston 13 A and a second piston 13 B respectively associated with each of the syringes 10 A, 10 B.
  • Each of the pistons 13 A, 13 B is configured to drive a respective plunger 14 A, 14 B within a barrel of the respective syringe 10 A, 10 B.
  • the fluid injector system 2000 includes a controller 900 in electronic communication with various components of the system 2000 to execute an injection procedure.
  • the controller 900 may include at least one processor programmed or configured to actuate the pistons 13 A, 13 B and various other components of the injector system 2000 to deliver medical fluids according to a programmed protocol for an injection procedure, including, for example, monitoring at least one fluid property of one or more fluids being drawn into syringes 10 A, 10 B and determining at least one of fluid identity and fluid concentration.
  • the controller 900 may then adjust at least one parameter of the injection protocol based on the at least one of fluid identity and fluid concentration, such as switching the syringe identity in the injection protocol so that the correct fluid is identified with the correct syringe 10 and correct injection parameters are utilized, altering a display so that the syringe image on the display correctly represents the correct fluid in the syringe, switching a color of one or more light emitters (such as an LED light) associated with the syringe to display the correct light color associated with the correct fluid type (e.g., blue for saline, green for contrast, red for air), indicate on a display the concentration of the contrast agent, adjust an injection protocol to inject a correct ratio of contrast and saline when an incorrect contrast concentration has been loaded into the contrast syringe, and provide an alert to the user that one or more errors has occurred during a fluid fill operation, such as incorrect fluid filled into the syringe, bulk fluid container is empty as only air has been drawn into the syringe,
  • the controller 900 may include computer readable media, such as memory, on which one or more injection protocols may be stored for execution by the at least one processor. Controller 900 is configured to actuate pistons 13 A, 13 B to reciprocatively move the plungers 14 A, 14 B within syringes 10 A, 10 B and thereby execute and halt an injection procedure.
  • the fluid injector system 2000 may further include at least one graphical user interface (GUI) 11 through which an operator can interact with the controller 900 to view status of and control an injection procedure.
  • GUI graphical user interface
  • the associated controller 900 may operate the various components of the fluid injector, such as the air sensor modules described herein, to ensure a correct fluid type is flowing through the correct fluid path elements based on an associated bulk fluid container, and if the fluid type is not correct, controller 900 may make the necessary adjustments and notifications to the injection protocol based on the actual fluid identified with the specific fluid pump.
  • Controller 900 may be programmed or configured to execute a filling operation during which the piston 13 A, 13 B associated with each syringe 10 A, 10 B is withdrawn toward a proximal end of syringe 10 A, 10 B to draw injection fluid F (e.g. imaging contrast media or flushing fluid) into syringes 10 A, 10 B from bulk fluid containers 19 A, 19 B, respectively.
  • injection fluid F e.g. imaging contrast media or flushing fluid
  • controller 900 may be programmed or configured to selectively actuate various valves, stopcocks, or clamps (such as pinch clamps) to establish fluid communication between the respective syringes 10 A, 10 B and the bulk fluid containers 19 A.
  • controller 900 may make the necessary adjustments to the system, injection protocol, etc., or alert a user based on the identification of the one or more properties of the fluid in fill line 216 A or 216 B.
  • the controller 900 may be programmed or configured to execute a fluid delivery operation during which the piston 13 A, 13 B associated with one or both of the syringes 10 A, 10 B is moved toward a distal end of the syringe to inject injection fluid F into the first patient line 210 A and the second patient line 210 B, respectively, at a specified flow rate and time to deliver a desired amount of fluid F.
  • the controller 900 may be programmed or configured to selectively actuate various valves, stopcocks, and/or pinch clamps to establish fluid communication between the syringes 10 A, 10 B and the patient, via the patient lines 210 A. 210 B.
  • the patient lines 210 A, 210 B ultimately merge before connecting to the catheter 110 , for example at a turbulent mixing chamber as described in PCT International Application No. PCT/US2021/019507, the disclosure of which is incorporated herein in its entirety.
  • the system 2000 includes one or more sensors and/or sensor modules configured for detecting air and/or fluid in the fluid path elements associated with each syringe 10 A, 10 B, for example, fill lines 216 A, 216 B.
  • a first sensor module 300 A is arranged to be in operative communication with the first syringe tip 16 A
  • a second sensor module 300 B is arranged to be in operative communication with the second syringe tip 16 B.
  • the first and second sensor modules 300 A, 300 B may be associated with the fill lines 216 A, 216 B.
  • the sensor modules 300 A, 300 B are in electronic communication with the controller 900 so that the controller 900 can determine at least one property of a fluid content of a fluid path section 570 ) (associated with fluid lines 208 A, 208 B, 216 A, and/or 216 B) based on signals transmitted by the sensor modules 300 A, 300 B.
  • the controller 900 may be configured to determine an identity of the fluid in the fluid path section 570 , a concentration of a medical fluid in the fluid path section 570 , the presence of air in the fluid path section 570 , a priming status of the fluid path section 570 , a property of the fluid path section (e.g.
  • FIGS. 1 and 2 show the sensor modules 300 A, 300 B associated with the syringe tips 16 A, 16 B.
  • the sensor modules 300 A, 300 B may be associated with essentially any component of the fluid path set, including the syringe lines 208 A, 208 B, the fill lines 216 A. 216 B, or the patient lines 210 A, 210 B.
  • the system 2000 may further include a third sensor module 300 C, functionally analogous to the first and second sensor modules 300 A, 300 B, downstream of a merge point of the patient lines 210 A, 210 B.
  • each sensor module 300 A, 300 B. 300 C may include one or more sensors 310 each including an emitter 312 and a collector or detector 314 as illustrated in FIG. 3 .
  • the emitter 312 and the detector 314 are spaced apart from one another defining a gap G in which is positioned the operatively associated fluid path section 570 ).
  • the emitter 312 is configured to emit electromagnetic radiation ER (e.g. light) at a predetermined wavelength toward the detector 314 .
  • the electromagnetic radiation ER must pass through the fluid path section 570 to reach the detector 314 .
  • the fluid in the fluid path section 570 ) and, in some embodiments, the structure of the fluid path section 570 ) itself absorbs and/or refracts some amount of the electromagnetic radiation ER generated by the emitter 312 , and thus prevents that amount of electromagnetic radiation ER from reaching the detector 314 .
  • the contents of the fluid path section 570 and, in some embodiments, the structure of the fluid path section 570 itself causes the electromagnetic radiation ER to diverge or converge before reaching the detector 314 due to the refraction index of the fluid and the fluid path section 570 .
  • Difference in measured absorption and/or refraction may be used to differentiate between an empty sensor 310 compared to one in which fluid path section 570 has been operatively inserted into the field of the sensor 310 , where fluid path section 570 only contains air.
  • the signal from sensor 310 may further indicate whether the fluid path section 570 has been properly inserted into the sensor 310 .
  • the emitter 312 may be one or more light emitting diodes (LEDs) or liquid crystal configured to emit electromagnetic radiation ER at a predetermined wavelength (or range of wavelengths), although other emitter light sources are within the scope of the present disclosure.
  • the emitter 312 may be able to emit electromagnetic radiation ER at more than one wavelength, depending on the fluid to be measured.
  • the emitter 312 may be configured to emit light at a first wavelength and emit light a second or other wavelength depending on the requirements of the fluid injection procedure.
  • the detector 314 may be any detector capable of converting a quantity of received light into an electrical signal, for example a phototransistor, photoresistor, or a photodiode.
  • the detector 314 may be configured to measure an amount of received electromagnetic radiation ER at different specific wavelengths, depending on the wavelength emitted by the emitter 312 .
  • the controller 900 may be configured to control the wavelength of light emitted by the emitter 312 and detected by the detector 314 .
  • the emitter 312 is configured to emit electromagnetic radiation on the infrared (IR) spectrum, for example between about 700 nanometers (nm) and about 2000 nm.
  • the emitter 312 is configured to emit electromagnetic radiation on the ultraviolet (UV) spectrum, for example between about 10 nm and about 400 nm.
  • the electromagnetic radiation emitted by the emitter 312 may have a wavelength from about 700 nm to about 2000 nm, in some embodiments from about 1440 nm to about 1460 nm, and in specific embodiments of about 1450 nm. In other embodiments, the electromagnetic radiation emitted by the emitter 312 may have a wavelength within the IR spectrum from about 750) nm to about 950 nm, or in another embodiment from about 800 nm to about 900 nm, in some embodiments from about 880 nm to about 900 nm, and in specific embodiments about 890 nm.
  • the electromagnetic radiation emitted by the emitter 312 may have a wavelength within the UV spectrum from about 300 nm to about 400 nm, or in another embodiment from about 350 nm to about 400 nm, in some embodiments from about 390 nm to about 400 nm, and in specific embodiments about 395 nm.
  • the emitter 312 may be configured to emit acoustic, e.g. ultrasonic, energy, and the detector 314 may be configured to detect acoustic energy.
  • Electromagnetic radiation in the aforementioned wavelengths e.g. IR and UV wavelengths
  • the specific wavelength of electromagnetic radiation may be selected based on the fluids F used in the injection procedure and the structural properties of the fluid path section 570 ). Particularly, the wavelength(s) of electromagnetic radiation may be chosen that provide maximum differentiation in the output signal of the detector 314 for various fluids of concern.
  • the emitter 312 may be selected and/or configured to emit electromagnetic radiation of a wavelength that exhibits the greatest difference in transmission through saline and contrast media.
  • the emitter 312 may be configured to emit electromagnetic radiation at multiple wavelengths (either concurrently or in alternating pulses) to improve sensitivity of the sensor 310 .
  • the emitter 312 may be configured to emit electromagnetic radiation at a first wavelength optimized for differentiating between saline and contrast media, and to emit electromagnetic radiation at a second wavelength optimized for differentiating between concentrations of contrast media.
  • the wavelength(s) of electromagnetic radiation may be chosen to minimize adverse effects of factors on sensor performance, such as alignment of the electromagnetic radiation emitter 312 and detector 314 , alignment of fluid path set 570 ) with the emitter 312 and detector 314 : the material and geometry of the outer sidewall of fluid path section 570 ; and exposure of detector 314 to ambient light.
  • the span of the gap G between the emitter 312 and detector 314 may also be selected to maximize differentiation in the output signal of detector 314 for various fluids.
  • FIG. 3 illustrates the absence of a fluid path section in the gap G, so the electromagnetic radiation ER must pass through only the air in the gap G to reach the detector 314 .
  • FIG. 4 illustrates the fluid path section 570 placed in the gap G in operative association with the sensor 310 .
  • the fluid path section 570 in FIG. 4 is filled with the injection fluid F as would be expected during a filling operation of an injection procedure where fluid is moved from the bulk fluid container 19 A, 19 B to the syringe 10 A, 10 B.
  • the refractive index of the injection fluid F may cause the electromagnetic radiation ER passing through the fluid path section 570 to converge before reaching the detector 314 , thereby causing an increase in signal intensity received and measured by the detector 314 .
  • FIG. 5 illustrates the fluid path section 570 placed in the gap G in operative association with the sensor 310 , where the fluid path section 570 is filled with air as would be expected prior to priming the fluid path section 570 or initiating a filling operation of the syringe 10 A, 10 B, or which may occur if an air bubble is present in the injection fluid F during an injection procedure.
  • the refractive index of the air causes the electromagnetic radiation ER passing through the fluid path section 570 to diverge before reaching the detector 314 , thereby causing a decrease in signal intensity receive and measured by the detector 314 .
  • the absorption associated with the air-filled fluid path section 570 would absorb less light than a liquid filled fluid path section 570 ( FIG. 4 ) but would absorb more light than in a situation where the fluid path section 570 is not in gap G ( FIG. 3 ) due to the absorption of light by the polymeric material of the fluid path section sidewalls.
  • light absorption by the content between the emitter 312 and detector 314 may cause a difference in signal intensity measured by the detector 314 . For example, in FIG.
  • the light may pass freely from the emitter 312 to the detector 314 of the sensor 310 with only a minimum decrease in signal intensity, since air has only a minimal absorption of light from the emitter 312 (which can be factored into any calculation).
  • a fluid filled fluid path section 570 is inserted into sensor 310 , the signal of light passing from the emitter 312 to detector 314 is attenuated by absorption by the molecular makeup of the sidewalls of as well as the fluid within the fluid path section 570 .
  • detector 312 may be able to use a difference in light attenuation resulting from different liquids within the fluid path to differentiate between different contrast types or concentrations; or between contrast and saline, within fluid path section 570 ).
  • the detector 314 is configured to transmit an output signal (e.g. an output voltage) to the controller 900 based on signal strength from the detected electromagnetic radiation ER.
  • an output signal e.g. an output voltage
  • the output signal will be different depending on refractive index and absorption properties of the contents in the gap G, allowing the controller 900 to determine whether the fluid path section 570 is absent ( FIG. 3 ), the fluid path section 570 is present and filled with medical fluid F ( FIG. 4 ), or the fluid path section 570 is present and filled at least partially with air ( FIG. 5 ).
  • the controller 900 may determine a type of fluid (e.g. from a known database of commercially available contrast media solution) and/or a dilution ratio of fluid (i.e.
  • the sensor module 300 C downstream of the merge point of the patient lines 210 A, 210 B may be configured to measure dilution of the contrast from the first syringe 10 A by saline from the second syringe 10 B.
  • the emitter 312 , detector 314 , and fluid path section 570 are selected and arranged so that the output signal generated by the detector 314 is sufficiently different between fluid types that the sensor 310 is able to distinguish between the different contrast agent types and/or the different dilution ratios.
  • the emitter 312 , detector 314 , and fluid path section 570 are selected and arranged such that a range of output voltages of the detector 314 when saline is present in the fluid path section 570 does not overlap with a range of output voltages of the detector 314 when contrast media is present in the fluid path section 570 .
  • the emitter 312 , detector 314 , and fluid path section 570 are selected and arranged such that a range of output voltages of the detector 314 when a particular contrast type is present in the fluid path section 570 ) does not overlap with a range of output voltages of the detector 314 when a different contrast media type is present in the fluid path section 570 .
  • FIG. 23 illustrates an electrical schematic of the sensor 310 in accordance with an embodiment of the present disclosure.
  • the sensor 310 includes the emitter 312 and the detector 314 arranged such that the detector 314 receives electromagnetic radiation from the emitter 312 , with the received electromagnetic radiation being altered by the absorption and/or refraction of the fluid path section 570 and its contents.
  • the emitter 312 and detector 314 are powered by respective power supplies 320 , 321 .
  • the power supplies 320 , 321 may be 5 volt power supplies, which may be standalone devices or outputs of the controller 900 .
  • the power supply 320 associated with the emitter 312 allows the controller 900 to calibrate the emitter 312 by adjusting supplied current.
  • the power supply 321 supplies a fixed reference voltage to the detector 314 relating to the stability of the resulting output voltage of the sensor 310 .
  • the emitter 312 may include one or more LEDs emitting one or more specific wavelengths of electromagnetic radiation, with a current-limiting resistor 322 placed in series to maintain an appropriate forward current through the LED(s).
  • the detector 314 may be one or more phototransistors, photoresistors, or photodiodes with an associated sensor resistor 324 .
  • the sensor resistor 324 converts a current generated by the detector 314 in response to detecting electromagnetic radiation into an output voltage signal 326 to pass to the controller 900 .
  • sensor modules 300 A, 300 B may be provided in a manifold housing module 220 associated with fluid injector 12 .
  • the manifold housing module 220 may define a receiving channel 222 for removably receiving a manifold 500 of the fluid path set.
  • the manifold 500 may be a disposable component serving as a junction for the first syringe line 208 A, first patient line 210 A, and first fill line 216 A ( FIG. 2 ).
  • manifold 500 may include a first inlet port 510 connected to or integrally formed with syringe line 208 A, a first outlet port 512 connected to or integrally formed with patient line 210 A, and a first fill port 514 is connected to or integrally formed with fill line 216 A.
  • manifold 500 may serve as a junction for the second syringe line 208 B, second patient line 210 B, and second fill line 216 B ( FIG. 2 ).
  • the manifold 500 may include a second inlet port 520 connected to or integrally formed with syringe line 208 B, a second outlet port 522 connected to or integrally formed with patient line 210 B, and a second fill port 524 connected to or integrally formed with fill line 216 B.
  • the manifold 500 defines respective fluid path sections 570 adjacent to each of fill ports 514 , 524 that are configured to be operatively positioned between the emitter 312 and detector 314 of respective sensor modules 300 A, 300 B.
  • the manifold 500 may include at least one connecting beam 550 that, along with the receiving channel 222 , orients and positions the manifold 500 and correctly indexes and interfaces the fluid path sections 570 with the sensor modules 300 A, 300 B.
  • the manifold 500 is designed to allow a user to quickly and accurately install the tubing set into the manifold housing module 220 , such that the air detection regions of the fluid flow paths are correctly inserted into the reading portions of the sensor modules 300 A, 300 B.
  • the user may simply connect the syringe lines 208 A, 208 B to the syringes 10 A, 10 B, snap the manifold 500 into the manifold housing module 220 , and connect the fill lines 216 A, 216 B to the bulk fluid sources 19 A, 19 B (for example by spiking the fill lines 216 A, 216 B into the respective bulk fluid source 19 A. 19 B) and the fluid path set should be ready for priming.
  • the manifold 500 and the manifold housing module 220 may include complementary latching components, for example on the at least one connecting beam 550 , to releasably engage the manifold 500 with the manifold housing module 220 .
  • the manifold 500 and associated fluid path components may be a disposable component configured for use during a single injection procedure or for a series of injection procedures on a single patient.
  • the manifold 500 and associated fluid path components may be a disposable component of a multi-use portion of the fluid path set, which can be used in conjunction with multiple single-use portions, over several fluid injection procedures before being disposed of, for example after a set number of injections or 24 hours of use.
  • the fluid path sections 570 each include a sidewall 530 configured to allow passage of electromagnetic radiation from the emitters 312 to the detectors 314 when the fluid path sections 570 ) are disposed in operative association with the sensor modules 300 A, 300 B.
  • Each sidewall 530 is at least partially transparent to the predetermined wavelengths of electromagnetic radiation ER generated by the emitters 312 .
  • the sidewalls 530 may be made of an at least partially transparent material, such as a polymer, glass, transparent composite, crystal, or other suitable material.
  • the sidewall 530 may be constructed of a plastic material such as polyethylene terephthalate (PET), polycarbonate (PC), or polypropylene (PP) having a predetermined index of refraction.
  • PET polyethylene terephthalate
  • PC polycarbonate
  • PP polypropylene
  • the index of refraction of the sidewall 530 is closer to an index of refraction of water than to an index of refraction of air.
  • the sidewall 530 may be rigid so that the sidewall 530 cannot deflect, which could alter the path of electromagnetic radiation ER through the fluid path section 570 ) and cause unreliable sensor readings.
  • the sidewall 530 may be curved extending circumferentially around the outer surface of the fluid path section 570 .
  • the sidewall 530 may have one or more substantially planar exterior surfaces and interior surfaces. The one or more substantially planar surfaces may be located so that the path of electromagnetic radiation from the emitter 312 to the detector 314 passes through the one or more substantially planar surfaces.
  • the one or more substantially planar surfaces may minimize or eliminate any focusing or defocusing lensing effect by the surface on the beam of electromagnetic radiation as it passes through the first fluid path section 570 .
  • sidewall 530 may include or act as a lens to concentrate or disperse the electromagnetic radiation passing through the fluid path section 570 ).
  • sidewall 530 may have one or more flat surfaces, which may more predictably transmit light than curved surfaces, and in some embodiments, sidewall 530 ) may be a square tube.
  • sidewall 530 may have a surface finish to concentrate or disperse electromagnetic radiation passing through fluid path section 570 .
  • manifold 500 may include one or more check valves, such as check valves 516 , 526 respectively located in the fill ports 514 , 524 .
  • Check valves 516 , 526 may act to prevent backflow of fluid into the bulk fluid containers 19 A, 19 B during a pressurized injection.
  • additional check valves or actively-controlled valves e.g. stopcocks, pinch valves, etc.
  • the manifold 500 may include one or more encoded identifiers 580 , such as a barcode, QR-code, RFID tag or the like, for example located on the at least one connecting beam 550 ) or fluid path wall.
  • the fluid injector 12 may have an appropriately positioned reader 280 , such as a barcode reader, QR-code reader, RFID reader, associated with the manifold housing module 220 .
  • the encoded identifier 580 is read by the reader to determine one or more property of the manifold 500 and associated fluid path elements, such as at least one of: that the manifold 500 is correctly inserted, that the correct manifold 500 for the injection procedure, that the manufacture date of the manifold 500 and associated fluid path components is within the required time frame, and to determine whether the manufacturer of the manifold 500 is an approved manufacturer. If the controller 900 determines that the encoded identifier indicated that there may be an issue with the manifold 500 , the controller 900 may alert the user and require correction of the issue before the fluid injection procedure may be performed.
  • the manifold housing module 220 may include additional sensor modules 300 X, 300 Y associated with the fluid path sections adjacent the respective inlet port 510 , 520 .
  • the additional sensor modules 300 X, 300 Y may generally be similar in structure to the sensor modules 300 A, 300 B. However, various attributes of the additional sensor modules 300 X, 300 Y may differ from the sensor modules 300 A, 300 B in order to facilitate different functions.
  • the additional sensor modules 300 X, 300 Y may be particularly configured for air bubble detection and analysis, as described in PCT International Application PCT/US2022/017812, filed 25 Feb. 2022, the disclosures of each of which are incorporated herein by this reference. Further details of the structure and function of the manifold 500 and the manifold housing module 220 are shown in PCT International Application PCT/US2022/017812.
  • sensor modules 300 A, 300 B is illustrated in operative association with a corresponding syringe tip 16 A, 16 B so as to detect fluid in the fluid path section 570 entering the corresponding syringe 10 A, 10 B during a filling operation.
  • the syringe tips 16 A, 16 B themselves may serve as fluid path sections aligned with the sensor 310 , or a separate fluid path section 570 may be attached to the syringe tips 16 A, 16 B and aligned with the sensor 310 .
  • the fluid path section 570 includes a sidewall 530 , which may be similar to the sidewall described in connection with FIG. 6 , that is at least partially transparent to the wavelength of electromagnetic radiation generated by the emitter 312 .
  • the sidewall 530 may be constructed of a plastic material such as polyethylene terephthalate (PET), polycarbonate (PC), or polypropylene (PP) having a predetermined index of refraction.
  • the index of refraction of the sidewall 530 is closer to an index of refraction of water than to an index of refraction of air.
  • the sidewall 530 may be rigid so that the sidewall 530 cannot deflect, which could alter the path of electromagnetic radiation ER through the fluid path section 570 ) and cause unreliable sensor readings.
  • the sidewall 530 may include or act as a lens to refract and concentrate or disperse the electromagnetic radiation passing through the fluid path section 570 .
  • the sidewall 530 may have a surface finish to concentrate or disperse the electromagnetic radiation passing through the fluid path section 570 .
  • the sensor modules 300 A, 300 B may be free to rotate about the syringe tips 16 A, 16 B to allow the operator freedom in positioning the sensor modules 300 A, 300 B, e.g., to avoid particular orientations that would receive large amounts of ambient light.
  • Optic filters 318 may be provided between the emitter 312 and detector 314 to prevent ambient light from affecting a measurement of detector 314 .
  • the emitter 312 and the detector 314 may be arranged in a wide diameter section Dw of the fluid path section 570 .
  • This arrangement forces the electromagnetic radiation emitted by the emitter 312 to travel through a relatively large diameter of fluid, allowing for more absorption and/or refraction of the electromagnetic radiation by the fluid.
  • Empirical testing has shown that the greater absorption allowed by larger diameter of fluid increases the differentiation in detector output signal between fluid types.
  • an increase in the diameter of the fluid path section 570 through which the electromagnetic radiation travels can lead to more reliable and improved determinations of the fluid properties within the fluid path section 570 ) by the controller 900 .
  • increasing diameter of the fluid path section 570 accentuates the difference in absorption in a squared relationship: i.e., a small increase in diameter of the fluid path section has a relatively larger impact on a fluid's absorption of electromagnetic radiation.
  • the sensor modules 300 A, 300 B may include a collimating aperture 350 associated with the emitter 312 and/or a collimating aperture 352 associated the detector 314 .
  • the collimating aperture 350 ) associated with the emitter 312 may restrict the electromagnetic radiation leaving the emitter 312 to a substantially straight trajectory toward the detector 314 .
  • the collimating aperture 352 associated with the detector 314 may limit the peripheral field of view of the detector 314 such that only electromagnetic radiation coming from the direction of the emitter 312 can reach the detectors 314 .
  • the collimating aperture 352 may shield the detector 314 from ambient light sources.
  • the collimating apertures 350 , 352 may have a lesser length than diameter. In some embodiments, the collimating apertures 350 , 352 may have a greater length than diameter.
  • the sensor modules 300 A, 300 B may include one or more additional sensors 410 , 410 ′ configured to provide further analysis of the fluid path section 570 .
  • the additional sensors 410 , 410 ′ may generally be similar in structure to the sensor 310 , so any features of the sensor 310 described herein may equally apply to the additional sensors 410 , 410 ′.
  • various attributes of the additional sensors 410 , 410 ′ may differ from the sensor 310 in order to facilitate different functions.
  • the additional sensors 410 , 410 ′ may be particularly configured for air bubble detection and analysis. Examples of additional sensors for determination of air bubble detection and analysis are presented in PCT International Application PCT/US2022/017812.
  • Respective emitters 412 , 412 ′ of the additional sensors 410 , 410 ′ may be configured to emit electromagnetic radiation at the same or a different wavelength than the sensor 310 .
  • the additional sensors 410 , 410 ′ are located downstream of the sensor 310 .
  • the additional sensors 410 , 410 ′ may be located upstream of the sensor 310 , or at an entirely different location in the fluid path set.
  • the sensor 310 and the additional sensors 410 , 410 ′ may be configured to differentiate between air and fluid (e.g., saline and contrast media) in the fluid path section 570 .
  • the additional sensors 410 , 410 ′ may be configured to work in tandem with the controller 900 to detect air bubbles in the fluid path section 570 , to determine the flow rate of detected air bubbles, and/or to determine the volume of detected air bubbles. Controller 900 may be configured to determine a flow rate of such detected air bubbles based on a time offset between the air bubbles being detected by the proximal detector 414 and distal detector 414 ′.
  • a manifold 600 including a fluid path section 670 may be attached to each syringe tip 16 A, 16 B, and the sensor modules 300 A, 300 B may be placed in operative association with the fluid path section 670 of the manifold 600 .
  • the manifold 600 and associated sidewall 630 may clip to or otherwise engage with corresponding features of on the tip 16 A, 16 B of syringes 10 A, 10 B by a clipping engagement mechanism as described in PCT International Application No. PCT/US2021/018523, the disclosure of which is incorporated by this reference.
  • the manifold 600 includes an inlet port 610 configured for connection to the syringe tip 16 A, 16 B with or without (as shown) intervening flexible tubing (i.e. the corresponding syringe line 208 A, 208 B).
  • the manifold 600 further includes an outlet port 612 configured for connection to the corresponding patient line 210 A, 210 B, and a fill port 614 configured for connection to the corresponding fill line 216 A, 216 B.
  • the fluid path section 670 includes a sidewall 630 , which may be substantially similar to the sidewall 530 shown and described in connection with FIGS. 6 and 7 .
  • the sensor modules 300 A, 300 B may be utilized for gross air detection within the fill lines 216 A, 216 B during an angiography (CV) or computed tomography (CT) procedure that accommodates refill of the syringes 10 A, 10 B during use from a bulk fluid containers 19 A, 19 B.
  • CV angiography
  • CT computed tomography
  • the sensor modules 300 A, 300 B may be used to distinguish between injection fluid F and air in the fluid path section 570 , to distinguish between two types of injection fluid common to the MR.
  • CV or CT injection procedures i.e., contrast types and saline
  • the controller 900 may be configured to automatically identify the fluid content of each syringe 10 A, 10 B based on the output signal of the detector 314 .
  • the controller 900 may display the contents of the syringes 10 A, 10 B to the operator, for example via a message or graphic on the GUI 11 or by a color associated with the fluid type (e.g., green or purple for contrast and blue for saline or other flushing solution).
  • the GUI 11 may graphically depict the syringes 10 A, 10 B, showing each in a predetermined color depending on the contents of the syringes 10 A, 10 B. Presuming the syringes 10 A, 10 B are filled as expected, with the first syringe 10 A containing contrast media and the second syringe 10 B containing saline, the GUI 11 could illustrate the first syringe 10 A in green or purple and the second syringe 10 B in blue. It is understood that other colors may be used to represent certain fluid types and represent when air is detected the sensor modules 300 A, 300 B.
  • the controller 900 may illuminate the syringes 10 A, 10 B or other portions of the system 2000 to indicate the contents of the syringes 10 A, 10 B as determined by the sensor modules 300 A, 300 B and the controller 900 .
  • the controller 900 may illuminate a light source optically connected to each syringe 10 A, 10 B, with the syringes 10 A, 10 B acting as light tubes to display a color indicative of the fill contents of the syringes 10 A, 10 B (e.g. green for contrast media and blue for saline).
  • the plungers 14 A, 14 B may be backlit as described in U.S. Application Publication No. 2017/0056603, the disclosure of which is hereby incorporated by reference in its entirety, to indicate the contents of the syringes 10 A, 10 B as determined by sensor modules 300 A, 300 B.
  • the controller 900 may be configured to communicate a warning to the operator, for example on the GUI 11 or in the form of a warning alert (e.g., audible or visual), if there is an error in the fluid arrangement vis-à-vis the requirements of a prescribed injection protocol.
  • a warning alert e.g., audible or visual
  • the controller 900 may utilize a visual indication, for example a light display to indicate the absence of the fluid path section 570 in operative position in the sensor modules 300 A, 300 B (e.g., yellow warning light), the presence of air in the fluid path section 570 (e.g., red stop injection light), the presence of saline in the fluid path section 570 ) (blue light), or the presence of contrast media in the fluid path section 570 ) (e.g., green light).
  • the controller 900 may be configured to disable the injection procedure until a purging operation is performed and no further air is detected in the tubing, either automatically by the controller 900 or under direction of the operator.
  • the controller 900 may be configured to perform safety checks and/or adjust parameters of an injection procedure if a fault is detected prior to or during an injection.
  • the controller 900 via the sensor module 300 A associated with the first syringe 10 A, may monitor the fluid path section 570 during a filling operation in which contrast media is drawn from the bulk fluid container 19 A into the syringe 10 A.
  • the controller 900 may monitor the output signal of the detector 314 of the sensor module 300 A to determine whether first syringe 10 A is indeed receiving contrast media or is instead being filled with saline—for example because the operator incorrectly connected the bulk fluid containers 19 A, 19 B to the wrong syringes 10 A, 10 B.
  • the controller 900 may monitor the output signal of the detector 314 of the sensor module 300 B to determine whether the second syringe 10 B intended to be filled with saline is instead being filled with contrast media. If either or both conditions are true, the controller 900 can alert the operator, via a message displayed on the GUI 11 , and/or automatically stop the fill procedure.
  • the controller 900 is configured to continue with the fill procedure and adjust the injection protocol and GUI display so that the first syringe 10 A is shown as the saline syringe (i.e., by highlighting the syringe blue on the GUI) and the controller injects the saline from syringe 10 A using parameters that were programmed for saline and originally intended to be injected by the second syringe 10 B.
  • the controller 900 may adjust the injection protocol and GUI display so that the second syringe 10 A is shown as the contrast syringe (i.e., by highlighting the syringe green on the GUI) and the controller injects the contrast from syringe 10 B using parameters that were programmed for the contrast injection and originally intended to be injected by the first syringe 10 A.
  • the controller 900 may be configured to update the display of the GUI to indicate this reversal of which syringe delivers which medical fluid.
  • the controller 900 may be configured to adjust an injection ratio of contrast media to saline if the sensor module 300 A detects that the concentration of the contrast media in the first syringe 10 A is different than the concentration required by the injection protocol. If the controller 900 determines, based on the output signal of the sensor module 300 A, that the contrast media in the syringe 10 A is more concentrated than prescribed in the injection protocol, the controller 900 can alert the operator and/or automatically increase the ratio of saline injected during the procedure to dilute the concentration of the contrast media delivered to the patient. Similarly, in a dual flow procedure the controller 900 can reduce the injection rate of saline during the injection procedure to increase the concentration of the contrast media, for example if the contrast media in the first syringe 10 A is less concentrated than prescribed in the injection protocol.
  • the resulting output signal from the corresponding detector 314 may be used by the controller 900 as a calibration point against which the controller 900 can assess subsequent output signals from the detector 314 .
  • the fluid path section 570 contains air or an air bubble, a lower level of light transmission occurs through the fluid path section, for example due to absorption or scattering of light by the sidewall 530 , such that less light reaches the detector 314 , resulting in a lower detector output voltage.
  • the fluid light adsorption properties and/or index of refraction causes the light to be absorbed and/or refract as it travels through the fluid path section 570 , resulting in an even lower level of light reaching the detector 314 compared to air in the fluid path section 570 .
  • the type of fluid affects the light transmission properties.
  • saline absorbs/refracts a first amount of light to the detector 314 greater than the amount of light absorbed/refracted by an air filled fluid path section 570 , due to the solute (salts) dissolved in the aqueous solution, resulting in a first voltage readout lower than for air or for the absence of the fluid path section 570 .
  • Contrast media absorbs/refracts a second amount of light to the detector 134 greater than the amount of light absorbed/refracted by a saline or air filled fluid path section 570 or no fluid path, due to the type of solute (contrast molecules) dissolved in the aqueous solution, resulting in a lower voltage readout.
  • the sensitivity of the detector 314 may also allow differentiation of different types of contrast and/or different concentrations of the same contrast media. For example, different concentrations of the same contrast media will have different densities due to different amounts of solute dissolved in the solution, resulting in different indexes of refraction and/or different amounts of light absorption. As such, the fluids will allow different levels of electromagnetic radiation to reach the detector 314 , resulting in different detector output voltage signals.
  • the controller 900 may be calibrated or may be configured to reference a database associated with output voltages of different contrast types or different contrast concentrations, for example in a look-up database programmed into the controller 900 .
  • the controller 900 may thus be able to determine which brand, type, and/or concentration of contrast media is in the first syringe 10 A (or in the second syringe 10 B in the event that the second syringe 10 B is inadvertently filled with contrast media) and update the GUI as necessary or alert the user that an incorrect contrast or an incorrect contrast concentration has been loaded into syringe 10 A.
  • the controller 900 may determine the type of fluid in the fluid path section in order to optimize fill time of the syringes 10 A, 10 B. By identifying the type of fluid in the fill fluid line 216 A, 216 B, the controller 900 may set a predetermined safe filling rate for the syringes 10 A, 10 B, i.e. a flow rate into the syringes 10 A, 10 B that minimizes the syringe fill time while reducing the occurrence of bubble generated in the fluid by excess flow rate of the fluid into the syringe.
  • a predetermined safe filling rate for the syringes 10 A, 10 B i.e. a flow rate into the syringes 10 A, 10 B that minimizes the syringe fill time while reducing the occurrence of bubble generated in the fluid by excess flow rate of the fluid into the syringe.
  • the controller 900 may store and utilize the results of air detection and correlate them to specific fill speeds so that an optimal fill rate (fastest speed) may be determined that prevents or reduces introduction of air bubbles into the fluid in the syringes 10 A, 10 B.
  • an optimal fill rate fastest speed
  • a predetermined safe filling rate for saline may be higher than a predetermined safe filling rate of contrast media.
  • a histogram 2100 shows empirically observed output voltages of the detector 314 for various fluids in the fluid path section 570 operatively associated with the sensor 310 .
  • the wavelength of light according utilized in FIGS. 8 A and 8 B was 890 nm.
  • the voltages were measured in 0.188 inch outer diameter tubing with infrared light generated by the emitter 312 , and with a sensor gap G of 0.228 inches.
  • the gap G of 0.228 inches was found to be the optimal size for obtaining signal differentiation in 0.188 inch tube.
  • the observed output voltages of the detector 314 for an empty tube i.e.
  • the observed output voltages of the detector 314 for contrast in the fluid path section 570 fell in a range of 4.75 volts to 5 volts.
  • the clustering of voltage outputs exhibited by the various fluids (or lack thereof) in the fluid path section 570 illustrate that the sensor 310 may reliably differentiate between these fluid types based on the output voltage of the detector 314 .
  • a graph 2150 shows the standard deviation of detector output voltages over several test measurements of various fluids in the fluid path section 570 , again using infrared light and a gap G of 0.228 inches as shown in FIG. 8 A .
  • the fluids for which data is shown include saline (for which three sets of data were analyzed) and the following commercially available contrast media solutions: Ultravist® 370 , Ultravist® 300 , OmnipaqueTM 240 , OmnipaqueTM 350 , Isovue® 370 , Isovue® 300 , and Isovue® 250 .
  • the controller 900 may be programmed with predetermined thresholds, such as upper bounds and lower bounds, associated with air, saline, and various types of contrast media. During an injection procedure, if the output signal from the detector 314 falls within the predetermined upper and lower bounds associated with air, the controller 900 determines that air is present in the fluid path section 570 .
  • the controller 900 determines that contrast media is present in the fluid path section 570 .
  • only an upper bound or only a lower bound may be used as one of the predetermined thresholds.
  • the controller 900 may not have an upper bound associated with air, as the output voltage signal of saline or contrast media would never be less than that of air.
  • the controller 900 may interpret an output signal significantly outside an expected range of values as a fault condition and may alert the operator (for example via a message displayed on the GUI 11 ) and/or automatically halt the injection procedure. For example, if the output signal is above 5 volts in this embodiment, which as evident from graph 2100 is greater than the expected output voltage associated with any fluid in the fluid path section 570 , the controller 900 may determine that a fault has occurred.
  • graph 2200 shows empirically observed detector output signal voltages for water, contrast media, and a 50:50 solution of water and contrast media, again for the emitter 312 operating at 1450 nm.
  • the average detector output voltage for water in the fluid path section 570 is between 150 millivolt (mV) and 200 mV
  • the average detector output voltage for a 50:50 solution of contrast and water in the fluid path section 570 ) is between 200 mV and 250 mV
  • the average detector output voltage for contrast media in the fluid path section 570 is between 250 mV and 300 mV.
  • graph 2300 shows empirically observed detector output signal voltages for water, contrast media, and a 50:50 solution of water and contrast media, in an embodiment in which the emitter 312 generates electromagnetic radiation on the ultraviolet spectrum at 395 nm.
  • the average detector output voltage for water in the fluid path section 570 is between 1600 mV and 1800 mV
  • the average detector output voltage for a 50:50 solution of contrast media and water in the fluid path section 570 is between 1400 mV and 1600 mV
  • the average detector output voltage for contrast media in the fluid path section 570 is approximately 1200 mV.
  • graph 2400 shows empirically observed detector output signal voltages for various dilution ratios of contrast media to water, again in an embodiment in which the emitter 312 generates electromagnetic radiation on the UV spectrum at about 395 nm.
  • the average detector output voltage for 100% contrast media in the fluid path section 570 is approximately 1200 mV, and the average detector output voltage gradually increases at 75% contrast. 50% contrast, 25% contrast, and 0% contrast (100% water).
  • the percentage of contrast media in the solution has an inverse effect on the output voltage of the detector 314 .
  • FIGS. 8 A- 11 merely show data for a small number of embodiments, with specific configurations of the sensor 310 .
  • Other configurations which may use a different type of emitter 312 or detector 314 , different circuitry associated with the emitter 312 or detector 314 , different gap spacing between the emitter 312 and the detector 314 , different tubing diameters, different strengths of electromagnetic radiation, and/or different optical lenses or filters may produce different output voltages when detecting the same fluids as illustrated in FIGS. 8 A- 11 .
  • the detector 314 may output a voltage of approximately 1.609 volts if the fluid path section is not present, approximately 0.609 volts if the fluid path section is filled with air, approximately 3.43 volts if the fluid path section is filled with saline, and approximately 4.65 volts if the fluid path section is filled with contrast media. In other embodiments, the detector 314 may output a voltage of approximately 5.0 volts if the fluid path section is not present, approximately 2.5 volts if the fluid path section is filled with air, and approximately 1.0 volts if the fluid path section is filled with contrast media. Detector output voltages may be manipulated to a certain extent through calibration (e.g. changing the resistor 322 , 324 in the sensor circuit of FIG. 23 ) to produce output voltages with greater sensitivity.
  • graphs 2500 - 2800 illustrate various empirically observed transmission percentages for electromagnetic radiation through various commercially available contrast media solutions as a function of wavelength generated by the emitter 312 .
  • graph 2500 shows experimental data gathered for relative transmission of electromagnetic radiation through various dilutions of Ultravist® 370 contrast media in a 10 millimeter (mm) glass cuvette. Transmission of electromagnetic radiation through water in a 10 mm glass cuvette is also shown as a baseline value, with essentially 100% transmission rate.
  • the graphed dilutions include pure Ultravist® 370 and ratios of 1:1, 2:1, and 3:1 water to Ultravist® 370 .
  • the greatest differentiation in relative transmission between the various dilutions occurs in or near the UV spectrum, for example at a region from 370 to 390 nm, and in particular approximately 379 nm in this embodiment.
  • the difference in relative transmission at a given wavelength can be used to differentiate between saline (similar to water) and contrast, and between the various dilutions of contrast with water.
  • the detector 314 detects the electromagnetic radiation transmitted through the fluid in the fluid path section 570 , so differences in transmission percentages of the various dilutions result in different amounts of electromagnetic radiation reaching the detector 314 . Consequently, the resulting output signal generated by the detector 314 will be different for water and contrast dilutions having different transmission percentages at a given wavelength.
  • the controller 900 may be able to determine approximately which dilution ratio of Ultravist® 370 is present in the fluid path section 570 ) based on the output signal of the detector 314 .
  • the controller 900 may be configured to match the output voltage of the detector 314 to known output voltages associated with various dilutions of Ultravist® 370 .
  • the controller 900 may be configured to reference a database of known output voltages associated with various dilutions.
  • the controller 900 may be configured to interpolate a dilution ratio of Ultravist® 370 based on the output voltage of the detector 314 .
  • graph 2600 shows transmission percentage of electromagnetic radiation with wavelengths falling between 350 and 450 nm through various commercially available contrast media solutions including Isovue® 128 . Isovue® 250 , Isovue® 370 . OmnipaqueTM 300 , and Ultravist® 370 .
  • Graph 2700 of FIG. 14 shows the same data as graph 2600 but expanded for electromagnetic radiation with wavelengths falling between about 200 and about 1020 nm.
  • Graph 2800 of FIG. 15 shows transmission percentage of the same commercially available contrast media solutions for electromagnetic radiation with wavelengths falling between 900 nm and 1050 nm. As noted in FIG.
  • the difference in relative transmission at a given wavelength may be used to differentiate between the various contrast media solutions.
  • the greatest differentiation in transmission percentage of the various contrast media solution may occur in or near the infrared and ultraviolet regions of the electromagnetic spectrums.
  • the emitter 312 may be configured to generate electromagnetic radiation in or near the infrared and ultraviolet spectrums to take advantage of this differentiation. In other embodiments, the emitter 312 may be configured to generate electromagnetic radiation in the visible spectrum.
  • the emitter 312 may be able to generate electromagnetic radiation at two or more different wavelengths, such as two wavelengths within the infrared region of the electromagnetic spectrum, two wavelengths within the ultraviolet region of the electromagnetic spectrum, or at a wavelength in the infrared region and a wavelength in the ultraviolet region of the electromagnetic spectrum. Accordingly, the emitter 312 may pulse electromagnetic radiation at different wavelengths through the fluid path section 570 to gather several absorption/transmission data points on the fluid in the fluid path section 570 to more accurately determine the identity of the fluid within the fluid path section 570 .
  • the controller 900 may be configured to determine which of the contrast media solutions is present in the fluid path section 570 based on the output signal of the detector 314 .
  • the controller 900 may be configured to match the output voltage of the detector 314 to known output voltages associated with various commercially available contrast media solutions.
  • the controller 900 may be configured to reference a database of known output voltages associated with various commercially available contrast media solutions.
  • FIGS. 16 - 20 various tubing geometries and manufacturing defects which may be present in the fluid path section associated with the sensor 310 are shown.
  • FIG. 16 shows an eccentricity in which a lumen 580 of the fluid path section is not concentric with the sidewall 530 .
  • FIG. 17 shows a draft in which the inner diameter and/or outer diameter of the sidewall 530 tapers in a proximal-to-distal direction.
  • FIG. 18 shows a surface finish 582 applied to the sidewall 530 .
  • certain surface finishes may be intentional to manipulate the convergence and/or divergence of the electromagnetic radiation passing through the sidewall 530 . However, other surface finishes and/or inconsistently applied surface finished may adversely affect sensor readings.
  • FIG. 16 shows an eccentricity in which a lumen 580 of the fluid path section is not concentric with the sidewall 530 .
  • FIG. 17 shows a draft in which the inner diameter and/or outer diameter of the sidewall 530 tapers in a proximal-to
  • FIGS. 16 - 20 show an oval tube in which the inner diameter and/or outer diameter of the sidewall 530 are out of round.
  • FIG. 20 shows a wisp 584 in the sidewall 530 , for example an inclusion in the base material or a molding line imparted during manufacturing.
  • Each of the features shown in FIGS. 16 - 20 may cause the electromagnetic radiation passing through the fluid path section to behave in unexpected ways, which can result in spurious and unreliable output signals from the detector 314 .
  • differentiating between types of contrast media requires the most sensitivity, and as such the types of tubing irregularities shown in FIGS. 16 - 20 may have the most pronounced influence in this type of differentiation.
  • differentiating between air and contrast media, air and saline, and contrast media and saline required less sensitivity, so tubing irregularities of FIGS. 16 - 20 may have lesser or negligible effects on these determinations.
  • the controller 900 may be configured to perform a test measurement prior to the injection and/or syringe filling procedure to establish the presence of and potential effects of these geometry features/defects on the output signals from the detectors 314 .
  • the controller 900 may use the results of the test measurement to calibrate the detector 314 and/or to calculate one or more correction factors based in the effects of the features/defects in one or both the contrast injection fluid paths and the flushing fluid paths.
  • the controller 900 may apply the correction factor to the output signals from the detector 314 to compensate for the manufacturing feature/defects.
  • An additional manufacturing issue that can affect sensor readings is the inner diameter of the sidewall 530 being different from an expected value. This can occur due to manufacturing tolerances and/or the use of third party fluid path set components.
  • An unexpected inner diameter of the sidewall 530 can particularly effect air bubble volume calculations, as the controller 900 may utilize a predetermined diameter constant corresponding to the inner diameter to convert the detected length of the air bubble into a volume. If the actual inner diameter of the sidewall 530 is different than predetermined diameter constant, the calculation of air bubble volume may be inaccurate.
  • the controller 900 may be configured to perform a test measurement prior to the injection procedure to establish the sidewall outer diameter, inner diameter, and thickness based on the detected refraction of the empty fluid path section. Based on the test measurement, the controller 900 may apply a correction factor to subsequent output signals from the detectors 314 .
  • the controller 900 may be configured to manipulate the intensity and/or wavelength of the electromagnetic radiation generated by the emitter 312 to enhance the sensitivity and/or gather additional information from the sensor 310 .
  • the controller 900 may increase the current to the emitter 312 , causing the emitter 312 to emit light at a high intensity, or decrease the current to the emitter 312 , causing the emitter 312 to emit light at a lower intensity.
  • the controller 900 may power the emitter 312 at a predetermined intensity known to saturate the detector 314 .
  • FIGS. 21 A- 21 D illustrate detector output voltage as a function of emitter current for an arbitrary embodiment of the sensor 310 .
  • the detector 314 has a dark level, corresponding to minimum output voltage, and a saturation limit, corresponding to a maximum output voltage.
  • FIG. 21 A illustrates a first emitter current 702 , selected to produce a first detector output voltage 802 between the dark level and the saturation limit of the detector 314 .
  • FIG. 21 B illustrates a second emitter current 704 that is greater than the first emitter current 702 , consequently causing the detector 314 to produce a second detector output voltage 804 greater than the first output voltage 802 . In this case, the second detector output voltage 804 is still below the saturation limit of the detector 314 .
  • FIG. 21 C illustrates a third emitter current 706 that is greater than the second emitter current 704 , consequently causing the detector 314 to produce a third detector output voltage 806 greater than the second detector output voltage 804 . In this case, the third emitter current 706 produces sufficient light intensity that the detector 314 is saturated, and thus the third detector output voltage 806 is at the saturation limit.
  • FIG. 21 B illustrates a second emitter current 704 that is greater than the first emitter current 702 , consequently causing the detector 314 to produce a second detector output voltage 804 greater than the first output voltage 802 . In this case, the second detector output voltage 804 is still below the saturation limit of the detector 314
  • 21 D illustrates a fourth emitter current 708 that is greater than the third emitter current 706 .
  • a fourth detector output voltage 808 produced by the fourth emitter current 708 is substantially equal to the third detector output voltage 806 . Further increases in the emitter current will likewise not result in an increase in output voltage of the detector 314 .
  • the saturation limit for a given detector 314 is substantially constant. Because the refraction and absorption characteristics of the contents between the emitter 312 and detector 314 affect the amount and/or intensity of light that reaches the detector 314 , the refraction and absorption characteristics of the fluid in the fluid path section (and the fluid path section itself) will determine the emitter current required to reach the saturation limit of the detector 314 .
  • the controller 900 may utilize the known saturation limit of the detector 314 to differentiate between fluids, e.g. air, saline, and contrast, and to differentiate between types and/or concentrations of contrast. For example, the controller 900 may drive the emitter 312 with a current that would be sufficient to saturate the detector 314 if only air was present in the fluid path section.
  • the controller 900 may determine that only air is present in the fluid path section. However, if the detector output voltage does not reach the saturation limit in response to this emitter current, the controller 900 may determine that another fluid is present. In some embodiments, the controller 900 may continue to modulate the current to the emitter 312 to further deduce the type and/or concentration of fluid in the fluid path section. For example, the controller 900 may drive the emitter 312 with a current that would be sufficient to saturate the detector 314 if the fluid in the fluid path section included less than a predetermined ratio of contrast to saline. If the detector output voltage reached the saturation limit in response to this emitter current, the controller 900 may determine that the fluid in the fluid path section has less than the predetermined ratio of contrast to saline
  • FIGS. 21 E- 21 H illustrate this method of determining fluid content of the fluid path section by incrementally increasing emitter current.
  • the controller 900 drives the emitter 312 at a fifth emitter current 750 , corresponding to a known current that will not saturate the detector 314 even if only air is present in the fluid path section.
  • a detector output voltage associated with air 850 a detector output voltage associated with a first contrast solution 852 , a detector output voltage associated with a second contrast solution 854 , and a detector output voltage associated with a third contrast solution 856 are all below the saturation limit of the detector 314 .
  • the detector output voltage associated with air 850 is sufficiently differentiated from the detector output voltages associated with the contrast solutions 852 , 854 , 856 that the controller 900 may be able to conclude, based on the actual measured detector output voltage of the detector 314 , that air is present in the fluid path section. It is noted that at the fifth emitter current 750 ), detector output voltages associated with the second contrast solution and the third contrast solution 854 , 856 are substantially at the dark level of the detector 314 , and therefore controller 900 cannot effectively differentiate between the second and third contrast solutions 854 , 856 at the fifth emitter current 750 .
  • the controller 900 may increase the current to the emitter 312 in order to improve the ability to differentiate between the fluids, particularly the first, second, and third contrast solutions 852 , 854 , 856 . To do so, the controller 900 may drive the emitter 312 at a sixth emitter current 752 greater than the fifth emitter current 750 . At the sixth emitter current 752 , the detector output voltage associated with air 850 is at the saturation limit of detector 314 . The detector output voltage associated with the second contrast solution 854 has moved out of the dark level and is therefore within the effective resolution of the detector 314 .
  • controller 900 may be able to differentiate between particularly the first and second contrast solution 852 , 852 , based on the actual output voltage of detector 314 . Further, by a method of elimination, contrast solution 856 may be eliminated as if still falls within the dark level.
  • the controller 900 may again increase the current to the emitter 312 in order to improve the ability to differentiate between the fluids, particularly the second and third contrast solutions 854 , 856 .
  • the detector output voltages associated with air 850 and first contrast solution 852 are at the saturation limit of the detector 314 .
  • the detector output voltage associated with the third contrast solution 856 has moved out of the dark level.
  • the spread between the detector output voltages associated with the second and third contrast solution 854 , 856 has increased, making differentiation between the second and third contrast solution 854 , 856 easier and/or more reliable at the seventh emitter current 754 compared to the sixth emitter current 752 .
  • the controller 900 may again increase the current to the emitter 312 to an eighth emitter current 758 .
  • the detector output voltages associated with air 850 , first contrast solution 852 , and second contrast solution 854 are at the saturation limit of the detector 314 .
  • controller 900 may be able to determine that the third contrast solution 856 is present in fluid path section if the actual detector output voltage of detector 314 is any value below the saturation limit.
  • Controller 900 may be configured to incrementally modulate the current diving the emitter 312 at predetermined time intervals to analyze the fluid content of the fluid path section as described in connection with FIGS. 21 A- 21 H .
  • a graph of exemplary output signals of the detector 314 is shown for the sensor 310 arranged in operative association with syringe tips 16 A, 16 B (as shown in FIG. 7 or FIG. 24 ) of three difference internal diameters (Syringe cap “A” of 0.122 inches, Syringe cap “B” of 0.165 inches, and Syringe cap “C” of 0.210 inches).
  • Tests were performed for each of Syringe Caps “A”, “B”, and “C” for three different conditions: the syringe cap not in operative association with the sensor module 300 A, 300 B; the syringe cap in operative association with the sensor module 300 A, 300 B and filled with air; and the syringe cap in operative association with the sensor module 300 A, 300 B and filled with water.
  • the output signals from the detector 314 allow the controller 900 to discriminate between these three conditions regardless of the internal diameter of the syringe cap.
  • the mean output signals for the syringe cap not in operative association with the sensor ranged from 4.110 to 4.111 volts; the mean output signals for the syringe cap filled with air ranged from 2.120 to 2.665 volts; and the mean output signals for the syringe cap filled with water ranged from 1.102 to 1.283 volts.
  • the emitter 312 operated at a wavelength of 1450 nm.

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AU2022295668A1 (en) 2023-11-30
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EP4355382A1 (en) 2024-04-24
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CA3223779A1 (en) 2022-12-22
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